US FDA Office of New Drugs director Peter Stein attempted to explain at a recent National Academies meeting on accelerated approval how the agency determines that a surrogate endpoint has been deemed reasonably likely to predict clinical benefit.
‘No Simple Formula’: US FDA Decisions On Surrogate Endpoints Are Complex, Case-Specific
Office of New Drugs’ Peter Stein runs down the types of evidence and other considerations weighed in determining that a surrogate is reasonably likely to predict clinical benefit; however, some panelists at a National Academies meeting say the agency needs to increase transparency around its thinking on surrogates that can support accelerated approval.
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